MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RE-ENTRY MALECOT NEPHROSTOMY CATHETER SET; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number	M0064101060
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to 10/01/2019 as no event date was reported.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 or Problem Description
It was reported to boston scientific corporation that a malecot nephrostomy catheter was unpacked on an unknown date.According to the complainant, the sterile plastic packaging of the nephro catheters has holes in it.
Additional Manufacturer Narrative
Date of event: date of event was approximated to 10/01/2019 as no event date was reported.Problem code 2385 captures the reportable event of hole in sterile packaging.Investigation result: visual examination found that an unused malecot nephrostomy catheter was received.It was noted that the heat seal runs throughout the entire length of the pouch without any breakage.The package was noticed to have signs of manipulation.It was also noted that the package was bent in the middle and there are some holes in the pouch and marks towards the holes were visible indicating interaction with an unknown object.It is most likely that the manner the box was manipulated, transported and/or stored after it left the manufacturing process was not appropriate and resulted in the damages found; therefore the most probable root cause is cause traced to transport/storage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a malecot nephrostomy catheter was unpacked on an unknown date.According to the complainant, the sterile plastic packaging of the nephro catheters has holes in it.

• Brand Name: RE-ENTRY MALECOT NEPHROSTOMY CATHETER SET
• Common Device Name: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9218976
• Report Number: 3005099803-2019-05124
• Device Sequence Number: 16732300
• Product Code: GBO
• UDI-Device Identifier: 08714729005308
• UDI-Public: 08714729005308
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K820867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: M0064101060
• Device Catalogue Number: 410-106
• Device Lot Number: 0019793369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/26/2019
• Patient Sequence Number: 1