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

Model Number M00546600

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2019

Event Type  malfunction  

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 Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the working channel sleeve of the spyscope ds protruded.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Event Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the working channel sleeve of the spyscope ds protruded.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Block e1 (initial reporter address 1): (b)(6).Block h6 (device codes): the problem code 2979 captures the reportable event of working channel sleeve protrusion.Block h10: a visual assessment was performed.As received, the working channel sleeve (wcs) protruded.Maximum wcs protrusion was observed when the distal tip was articulated by turning the large knob in the clockwise direction.The distal tip was cut.The distal cap was removed.The catheter was cut open using the cutting fixture.The wcs was removed.Witness marks were noted on the pebax.The white areas along bond a appear to show evidence of adhesion.These observations indicate that this device was manufactured correctly.However, the investigation of similar devices revealed a manufacturing issue related to bond b.Manufacturing process improvements have been implemented to address this issue.The complaint was consistent with the reported event of working channel sleeve protrusion.Based on investigation results, the probable cause selected for the wcs protrusion issue is manufacturing deficiency, which indicates that problems were traced to the manufacturing process.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: 8316730
• MDR Text Key: 135415338
• Report Number: 3005099803-2019-00566
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

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: Health Professional
• Device Expiration Date: 09/11/2020
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 22645010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 07/10/2019
• Supplement Dates FDA Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1