MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00546600

Device Problems Contamination (1120); Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 02/22/2019

Event Type  malfunction  

Manufacturer Narrative

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 spyscope digital access and delivery catheter was unpacked.According to the complainant, during unpacking, it was noticed that the inside of the package had water.There was no procedure involved and the device was not used in a patient.

Event Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was unpacked.According to the complainant, during unpacking, it was noticed that the inside of the package had water.There was no procedure involved and the device was not used in a patient.

Manufacturer Narrative

Block h6 (device codes): problem code 1444 captures the reportable event of unsealed device packaging.Problem code 1120 captures the reportable event of device not sterile.Block h10: visual examination of the returned unit was performed.It was returned unopened, and the device was inside of its original, sealed tray.There was evidence of water damage to most of the seal, confirming the complaint.The device did not appear to be damaged in the tray.The complaint was consistent with the reported complaint incident of packaging seal compromised.Based on investigation results, it is likely that water was exposed to the packaging during transport/storage.Therefore, the complaint investigation conclusion code selected is cause traced to transport/storage, which indicates that problems were traced to the inappropriate transport or storage of the device.A dhr (device history record) review was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint.The dhr review confirms that the accepted device met all manufacturing specifications.

• Brand Name: SPYSCOPE DS
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8430345
• MDR Text Key: 139162249
• Report Number: 3005099803-2019-01324
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: 08714729863236
• Combination Product (y/n): N
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

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
• Device Operator: Other
• Device Expiration Date: 01/28/2021
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 0023264248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/18/2019
• Supplement Dates Manufacturer Received: 04/05/2019
• Supplement Dates FDA Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1