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

Model Number M0063901050

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Unspecified Tissue Injury (4559)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

(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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a zero tip basket was used in the left kidney during a ureteroscopy procedure performed on (b)(6) 2021.During the procedure, a zero tip basket was used in an attempt to remove a stone but became embedded into the tissue.The basket was attempted to be removed, but a basket wire detached into the patient.The detached wire was unable to be retrieved.The procedure was not completed and was then cancelled.The patient is scheduled for a return surgery to retrieve the stone and detached wire.

Manufacturer Narrative

Block g2: medwatch # mw5099515.Block h2: additional information: b3 (date of event), block b5 (describe event of problem), block e4 (init rptr also sent rep to fda), block g2 (report source), block h6 (patient codes).Block h6: device code a0501 captures the reportable event of basket wire detached.Device code a27 is being used to capture the reportable event of additional procedure required.Block h10: a picture of the device pouch/label was submitted but no device failures could be visualized.Visual analysis found only one basket wire was attached to the device which confirms the reported event.The rest of the basket was not returned.The sheath was found torn at the distal section adjacent to the basket.Microscopic inspection found there is an indication that a laser or a similar tool burned the sheath and the pull wire at the distal section.Functional assessment cannot be performed due to the returned device condition.Based on all available information, it is likely that the problem happened due to manipulation of the device by the user.The sheath was found torn and presents evidence of burned material at the distal section adjacent to the basket.This condition could have been caused by a laser or a similar device.Additionally, because of this condition, the basket detached.The instructions for use (ifu) states "warnings: this device should not be directly fired upon by any lithotrite.To do so may damage the device and could result in patient injury.This device must not come in contact with any electrified instrument." therefore, the most probable root cause is unintended use error caused or contributed to event.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed, and there is evidence that the device was used not in accordance with the instructions for use (ifu) / product label, as the device has evidence of being fired upon with a laser.

Event Description

It was reported to boston scientific corporation that a zero tip basket was used in the left kidney during a ureteroscopy procedure performed on (b)(6) 2021.During the procedure, a zero tip basket was used in an attempt to remove a stone but became embedded into the tissue.The basket was attempted to be removed, but a basket wire detached into the patient.The detached wire was unable to be retrieved.The procedure was not completed and was then cancelled.The patient is scheduled for a return surgery to retrieve the stone and detached wire.Additional information received on march 18, 2021.The ureteroscopy procedure was performed on (b)(6) 2021.The basket wire detached in the left ureter during an attempt to remove a soft tissue.There was a large 4-5 cm soft tissue mass in the left renal pelvis and a 1.5 cm left lower pole renal stone.Additionally, there was a left proximal ureteral tissue tear as a result of the detached basket wire.The procedure was ended with a left jj stent placement.

Manufacturer Narrative

Block g2: medwatch # mw5099515.Block h6: device code a0501 captures the reportable event of basket wire detached.Device code a27 is being used to capture the reportable event of additional procedure required.Patient code e2008 captures the reportable event of unretrieved device fragment.Block h10: a picture of the device pouch/label was submitted but no device failures could be visualized.Visual analysis found only one basket wire was attached to the device which confirms the reported event.The rest of the basket was not returned.The sheath was found torn at the distal section adjacent to the basket.Microscopic inspection found there is an indication that a laser or a similar tool burned the sheath and the pull wire at the distal section.Functional assessment cannot be performed due to the returned device condition.Based on all available information, it is likely that the problem happened due to manipulation of the device by the user.The sheath was found torn and presents evidence of burned material at the distal section adjacent to the basket.This condition could have been caused by a laser or a similar device.Additionally, because of this condition, the basket detached.The instructions for use (ifu) states "warnings: this device should not be directly fired upon by any lithotrite.To do so may damage the device and could result in patient injury.This device must not come in contact with any electrified instrument." therefore, the most probable root cause is unintended use error caused or contributed to event.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed, and there is evidence that the device was used not in accordance with the instructions for use (ifu) / product label, as the device has evidence of being fired upon with a laser.Block h11: corrections: h6 (patient code), h10 (additional mfr narrative).

Event Description

It was reported to boston scientific corporation that a zero tip basket was used in the left kidney during a ureteroscopy procedure performed on (b)(6) 2021.During the procedure, a zero tip basket was used in an attempt to remove a stone but became embedded into the tissue.The basket was attempted to be removed, but a basket wire detached into the patient.The detached wire was unable to be retrieved.The procedure was not completed and was then cancelled.The patient is scheduled for a return surgery to retrieve the stone and detached wire.The ureteroscopy procedure was performed on (b)(6) 2021.The basket wire detached in the left ureter during an attempt to remove a soft tissue.There was a large 4-5 cm soft tissue mass in the left renal pelvis and a 1.5 cm left lower pole renal stone.Additionally, there was a left proximal ureteral tissue tear as a result of the detached basket wire.The procedure was ended with a left jj stent placement.

• 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: 11465796
• MDR Text Key: 239245638
• Report Number: 3005099803-2021-00989
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: 08714729469643
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2023
• Device Model Number: M0063901050
• Device Catalogue Number: 390-105
• Device Lot Number: 0026717770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 167