MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NEPHROSTOMY SHEATHS AND DILATORS; DILATOR, CATHETER

Model Number	M0062601070
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 or Problem Description
It was reported to boston scientific corporation that an amplatz renal dilator was delivered at the facility on (b)(6) 2019.According to the complainant, when the device arrived at the facility, it was noted that the sheath and the dilator was slightly bent which was confirmed by the photo sent by the customer.Moreover, a suspicion of crack was noted on the device sterile pouch and the sterility of the product has been compromised.This was found prior to use with a patient or procedure.
Additional Manufacturer Narrative
Block e1: initial reporter phone: (b)(6).Block h6: problem code 2385 captures the reportable event of sterile device packaging torn.Block h10: investigation result a visual examination of the returned complaint device found that an unused amplatz renal dilator 20f was returned.It was noted that the pouch is not torn, the heat seal runs throughout entire length of the pouch without any hole.However, it was noticed that the pouch has signs of handling/manipulation, it was wrinkled in some areas.Also, it was observed the dilator inside the pouch was bent.It is most likely that the failures found are related to the inappropriate transport or storage of the device; 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 an amplatz renal dilator was delivered at the facility on (b)(6) 2019.According to the complainant, when the device arrived at the facility, it was noted that the sheath and the dilator was slightly bent which was confirmed by the photo sent by the customer.Moreover, a suspicion of crack was noted on the device sterile pouch and the sterility of the product has been compromised.This was found prior to use with a patient or procedure.

• Brand Name: NEPHROSTOMY SHEATHS AND DILATORS
• Common Device Name: DILATOR, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8816388
• Report Number: 3005099803-2019-03720
• Device Sequence Number: 14267412
• Product Code: GCC
• UDI-Device Identifier: 08714729005490
• UDI-Public: 08714729005490
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K820865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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: 02/12/2023
• Device Model Number: M0062601070
• Device Catalogue Number: 260-107
• Device Lot Number: 0023342975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Initial Date Received by Manufacturer: 06/29/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1