MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMPULSE GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	8121
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a dissection occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman truseal access system (was) was positioned in the laa and a 24mm watchman flx laa closure device and delivery system (wds) was inserted into the was.The closure device was deployed, but was too proximal, so it was fully recaptured.It was deployed again, but did not meet the release criteria, so it was fully recaptured again.On the third deployment, the closure device did not expand.It was fully recaptured and removed from the patient.Another 24mm watchman flx closure device was used in a different lobe.It was deployed, but was too proximal, so a full recapture was performed and the wds was removed from the patient.An impulse pigtail catheter was inserted again into the was to achieve the very first position.After contrast was given, an intimal dissection was seen in the laa.The devices were removed and the procedure was aborted.The patient experienced low blood pressure and went to the emergency room where aterenol was administered.The patient is currently fine and has been discharged from the hospital.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an impulse diagnostic catheter.Analysis of the tip, and shaft included microscopic and visual inspection.Inspection found no damage or defect to the device.
Event or Problem Description
It was reported a dissection occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman truseal access system (was) was positioned in the laa and a 24mm watchman flx laa closure device and delivery system (wds) was inserted into the was.The closure device was deployed, but was too proximal, so it was fully recaptured.It was deployed again, but did not meet the release criteria, so it was fully recaptured again.On the third deployment, the closure device did not expand.It was fully recaptured and removed from the patient.Another 24mm watchman flx closure device was used in a different lobe.It was deployed, but was too proximal, so a full recapture was performed and the wds was removed from the patient.An impulse pigtail catheter was inserted again into the was to achieve the very first position.After contrast was given, an intimal dissection was seen in the laa.The devices were removed and the procedure was aborted.The patient experienced low blood pressure and went to the emergency room where aterenol was administered.The patient is currently fine and has been discharged from the hospital.

• Brand Name: IMPULSE GUIDE CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9484306
• Report Number: 2134265-2019-15821
• Device Sequence Number: 209501
• Product Code: DQO
• UDI-Device Identifier: 08714729200338
• UDI-Public: 08714729200338
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 8121
• Device Catalogue Number: 8121
• Device Lot Number: 0060189333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other