MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number M635WS30060

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: 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 medwatch will be filed.(b)(4).

Event Description

It was reported there was a pin-size hole in the shaft.A left atrial appendage (laa) closure procedure was being performed.A 30mm watchman ® laa closure device and delivery system (wds) was selected.During preparation, the wds was taken out of the plastic coil tubing and laid flat on the prepping table.The hemostasis valve was loosened and the core wire moved back to check the device was attached.Saline was used to flush the device; back flushing first, then tightening the hemostasis valve to proceed with forward flushing to remove any air from the device.After numerous attempts to remove the air, there was still a lot of bubbles.The outer shaft of the wds was examined and pin-size hole was observed in the down side of the outer shaft, reasonably close to the y-connector end and fluid was coming out as they attempted to prep.The device was replaced with another of the same size and the new device was prepped without issue and the implant was successful.No patient complications reported.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of the watchman delivery system (wds).No blood was visible on the device.The implant was inside the sheath and connected to the core wire.The hub, shaft, tip, markerband, core wire, and implant were microscopically examined.There were numerous kinks throughout the shaft of the wds.Shaft damage (perforation) was noted 32 mm from the hub.The implant was deployed during analysis and found to be consistent with the reported information.The implant showed no visible damage.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported there was a pin-size hole in the shaft.A left atrial appendage (laa) closure procedure was being performed.A 30mm watchman ® laa closure device & delivery system (wds) was selected.During preparation, the wds was taken out of the plastic coil tubing and laid flat on the prepping table.The hemostasis valve was loosened and the core wire moved back to check the device was attached.Saline was used to flush the device; back flushing first, then tightening the hemostasis valve to proceed with forward flushing to remove any air from the device.After numerous attempts to remove the air, there was still a lot of bubbles.The outer shaft of the wds was examined and pin-size hole was observed in the down side of the outer shaft, reasonably close to the y-connector end and fluid was coming out as they attempted to prep.The device was replaced with another of the same size and the new device was prepped without issue and the implant was successful.No patient complications reported.

• Brand Name: WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5818637
• MDR Text Key: 50302306
• Report Number: 2134265-2016-06776
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P130013
• 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: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: M635WS30060
• Device Catalogue Number: WS-3006
• Device Lot Number: 18418540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2015
• 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
• Patient Age: 69 YR