MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JINRO PIGTAIL; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number M0064202020

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a jinro pigtail nephrostomy catheter was placed in the kidney during a percutaneous nephrostomy procedure performed on an unknown date.Post procedure, it was noticed that the catheter was broken into two pieces.The broken catheter was removed from the patient and no new catheter was inserted after the event.There were no patient complications reported as a result of this event.Note: it was reported that prior to the event, the patient attempted to cut the catheter by himself, but unsuccessful at that time.Then, the hospital staff noticed that the catheter had been broken.

Manufacturer Narrative

Date of the event was approximated to (b)(6) 2022 based on the date the manufacturer became aware of the event.The complainant was unable to report the suspected lot number; therefore, the manufacture date and expiration date are unknown.(b)(4).

Manufacturer Narrative

Block b3: date of the event was approximated to 09/01/2022 based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to report the suspected lot number; therefore, the manufacture date and expiration date are unknown.Block h2: additional information: block b5 (describe event or problem) has been updated based on the additional information received on october 19, 2022.Block h6: medical device code a0401 captures the reportable event of catheter break.Block h10: investigation results the returned jinro pigtail nephrostomy catheter was analyzed, and a visual evaluation noted that the shaft of the catheter was broken.The connection tube was returned with the device.Microscopic examination was performed, and the broken catheter found was identified as a mechanical breakage and not a cut.No other problems were noted with the device.The reported event of catheter broken was confirmed.It is possible that the found problem of catheter breaking happened due to the user withdrawing the device with force, since the breakage encountered had evidence of mechanical breakage, consequently affecting the device performance and its intended purpose.A labeling review was performed and based on the condition of the returned device; this device was not used per the instructions for use (ifu)/product label.The instructions for use (ifu) states that "recommended catheter removal/replacement procedure; disconnect the drainage tube from the catheter hub.Gently withdraw the catheter.If access to the kidney is to be maintained, a 0.038 in (0.97mm) guidewire passed through the catheter may facilitate removal of the catheter, while maintaining access".According to the time of event, it occurred during "ongoing use" (after placement) meaning that the catheter must be removed with the steps before mentioned.Taking all available information into consideration, the most probable root cause is unintended use error caused or contributed to event since the interaction between the user and device, or sample, caused or contributed to the error.

Event Description

It was reported to boston scientific corporation that a jinro pigtail nephrostomy catheter was placed in the kidney during a percutaneous nephrostomy procedure performed on an unknown date.Post procedure, it was noticed that the catheter was broken into two pieces.The broken catheter was removed from the patient and no new catheter was inserted after the event.There were no patient complications reported as a result of this event.Note: it was reported that prior to the event, the patient attempted to cut the catheter by himself, but unsuccessful at that time.Then, the hospital staff noticed that the catheter had been broken.Additional information received on october 19, 2022: it was clarified that the part of the catheter that got broken was the one hanging outside the patient, and the broken catheter was pulled out of the patient by hand.

• Brand Name: JINRO PIGTAIL
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15595324
• MDR Text Key: 306619175
• Report Number: 3005099803-2022-05791
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K944290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0064202020
• Device Catalogue Number: 420-202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 10/19/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1