MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZERO TIP; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number UNK-P-ZERO_TIP_BASKETS

Device Problem Break (1069)

Patient Problems Pain (1994); Injury (2348); Hematuria (2558)

Event Date 10/27/2016

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a zero tip nitinol basket was used during a lithotripsy procedure for treatment of kidney stones performed on or about (b)(6) 2016.According to the complainant, post-procedure, the patient suffered from continuing pain and blood in his urine.The patient was advised by his operating physician that these conditions were normal and were to be expected as a result of the procedure.The patient went to visit his primary care physician, who advised that it was not normal to still have blood present in the urine.Imaging studies were taken, and revealed that an approximately 11cm portion of the zero tip basket and wire had been left inside of the patient from the lithotripsy procedure performed on or about (b)(6) 2016.It was reported that the patient underwent several unsuccessful attempts to remove the basket and wire, but was ultimately removed from the patient successfully.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Manufacturer Narrative

A2, a4, b5, b7, e1: additional information updated.D4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.E1: primary care physician for patient: (b)(6).H6: device problem code 1069 captures the reported event of basket detached.Investigation analysis: a zero tip basket was returned for analysis.A visual inspection of the zero tip basket revealed that the distal part of the basket was returned broken in five parts with white residues that appear to be anatomic residues.However, its composition was not confirmed.The formed basket leg wires appeared to be melted, blackened and discolored on several locations and the broken parts have irregular shape.The heat shrink was found torn, broken and whitened and/or stretched on areas where the basket wire was discolored.The unformed basket wires appeared detached from the splice joint section and no discoloration was present.Moreover, a scanning electron microscope (sem) imaging showed manufactured cut ends and no signs that they appear to be mechanically damaged.A functional inspection could not be performed due to the condition of the returned device.The damage found is consistent with damage caused when a medical professional applies laser on the device.Per additional information, medical records state that a laser was used during the initial basketing procedure that took place on october of 2017.Forceps were used to attempt to remove the device from the patient but the attempts were unsuccessful.The device was ultimately removed from the patient on december 2017, where a laser was used to cut the device fragment into smaller pieces and those pieces were removed.It is unknown if the laser impacted the basket wires on the original procedure (october 2017) or if it occurred during the removal.Based on available information, the conclusion code for the broken formed basket wires is failure to follow instructions since the problem was traced to the medical professional not following the manufacturer's instructions which state that the device must not come in contact with any electrified instrument.The device should not be directly fired upon by any lithotrite.Doing so may damage the device and could result in patient injury.The splice joint cannula attaches the unformed basket wires with the drive wire.In this case, the unformed basket wires appeared detached from the splice cannula since no discoloration or irregular surface is present.Since the splice cannula and proximal part of the device were not returned and no other type of testing can be performed due to legal requirements, there is not enough evidence to conclude how the end of the unformed basket wires got detached from the splice joint section.Therefore, the unformed basket wires detached from the splice joint is classified as cause not established since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.A labeling review was performed and no anomaly was found.

Event Description

It was reported to boston scientific corporation that a zero tip nitinol basket was used during a lithotripsy procedure for treatment of kidney stones performed on or about (b)(6) 2016.According to the complainant, post-procedure, the patient suffered from continuing pain and blood in his urine.The patient was advised by his operating physician that these conditions were normal and were to be expected as a result of the procedure.The patient went to visit his primary care physician, who advised that it was not normal to still have blood present in the urine.Imaging studies were taken, and revealed that an approximately 11cm portion of the zero tip basket and wire had been left inside of the patient from the lithotripsy procedure performed on or about (b)(6) 2016.It was reported that the patient underwent several unsuccessful attempts to remove the basket and wire, but was ultimately removed from the patient successfully.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.Additional information received on may 10, 2019.The correct procedure date is (b)(6) 2016.Procedures performed are the following: cystoscopy, left ureteroscopy, holmium laser lithotripsy, multiple basket stone extractions, left stent placement and c-arm fluoroscopy.During the procedure, a semirigid ureteroscope was passed into the bladder and into the left ureteral orifice.In the distal ureter, we immediately came upon multiple stone fragments.Using a basket, these are removed from the ureter and gently deposited in the bladder.The ureteroscope was reinserted and advanced under direct vision.We came upon a bunch more stones in the more proximal left ureter.These were too large to basket, so the 365 micron holmium laser fiber was placed, and standard laser lithotripsy was performed on the stones.Several stones migrated more proximally.These were followed up with the ureteroscope, and additional laser lithotripsy was performed.At this point, i feel any residual fragments should be able to pass with the stent in place, so the ureteroscope was removed, and the guidewire was backloaded over the cystoscope.The collecting system was opacified with dilute contrast, and it was noted that the kidney is somewhat hydronephrotic.Over the guidewire, a 7-french 26 cm double pigtail stent was passed in a standard retrograde fashion.When the guidewire was removed, we had a good coil in the dilated left renal pelvis as seen on fluoroscopy, and in the bladder, we had a good coil seen through the cystoscope.This completed the procedure.The bladder was emptied, and the cystoscope was removed.Lidocaine 2% jelly was injected into the urethra.He tolerated the procedure well with no apparent complications and was extubated and transported to the recovery room in stable condition.Additional information received on may 21, 2019.From the december 15, 2017 note from shands at uf: findings.Proximal left ureteral basket seen on ureteroscopy with areas embedded into the ureteral wall; able to follow it to the upper pole where the basket end piece was noted with areas embedded into the caliceal wall.Encrusted areas lasered to facilitate pulling the wire.We first worked on the distal end in the ureter removing the pieces after lasering it free.Then we worked in the upper pole basket end; lasering stone encrustation and then lasering it free.Forceps were used in earlier procedures to attempt to remove the device.Additional information received on may 22, 2019.Notes from the medical records indicate a laser was used at some point during the procedure.On (b)(6) 2017, forceps were used in an attempt to remove the retained, fragmented device on (b)(6) 2017, forceps were used during the second attempt to remove the retained, fragmented device.On (b)(6) 2017, the device was completely removed from the patient.A laser was used to break the device into five fragmented pieces.

• Brand Name: ZERO TIP
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7949761
• MDR Text Key: 123193689
• Report Number: 3005099803-2018-60715
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-P-ZERO_TIP_BASKETS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Date Manufacturer Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 120