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

Model Number M0063903200

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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 to be used in the ureter during a ureteroscopy (urs) procedure performed on (b)(6) 2017.According to the complainant, during unpacking, a hole was noted in the sterile packaging.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 visual evaluation of the returned device revealed a small hole and wrinkle in the lower left corner of the mylar side of the pouch.The tyvek side in the lower left corner of the pouch is wrinkled indicating that the hole was caused by handling.Since the returned package showed additional signs of damage, it is most likely that 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.Therefore, the most probable root cause for the complaint is handling damage.The device history record (dhr) review found the device met all manufacturing specifications.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was to be used in the ureter during a ureteroscopy (urs) procedure performed on (b)(6) 2017.According to the complainant, during unpacking, a hole was noted in the sterile packaging.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.

• 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: 7169415
• MDR Text Key: 96617306
• Report Number: 3005099803-2018-00013
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

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 Expiration Date: 02/28/2020
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: G35698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/05/2018
• Supplement Dates Manufacturer Received: 01/25/2018
• Supplement Dates FDA Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2017
• 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