MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL; DISLODGER, STONE, FLEXIBLE

Model Number M0063903200

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

(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 Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the kidney during a nephrolithotomy procedure performed on (b)(6) 2018.According to the complainant, during preparation, it was noted that the coil failed to straighten.Additionally, the distal part of the coil coating was found peeled.The procedure was completed with another stone cone nitinol urological retrieval coil.The patient's condition at the conclusion of the procedure was reported to be ¿stable¿.

Manufacturer Narrative

A stone cone retrieval coil was received for analysis.A visual analysis of the returned device found that the coating on the coil was peeled.The blue/green shrink is pulled away from the distal stop and is accordioned.Additionally, the white heat shrink near the proximal stop was also noted to be accordioned.A functional evaluation found that the device opens and closes freely.The complaint that the coating on the coil was peeled is confirmed.Since the damage occurred during preparation, the root cause for this event is handling damage.The complaint was caused by handling of the device or portion of the device without direct patient contact either during unpacking, preparation, or shipping; at the end of the procedure; or when packaging for return.The device history record (dhr) review found the device met all manufacturing specifications.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the kidney during a nephrolithotomy procedure performed on (b)(6) 2018.According to the complainant, during preparation, it was noted that the coil failed to straighten.Additionally, the distal part of the coil coating was found peeled.The procedure was completed with another stone cone nitinol urological retrieval coil.The patients' condition at the conclusion of the procedure was reported to be ¿stable¿.

• Brand Name: STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7453827
• MDR Text Key: 106395226
• Report Number: 3005099803-2018-01174
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2020
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0003815163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2017
• 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