MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	M001315051
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed (b)(4).
Event or Problem Description
Same case as mfr: 2134265-2017-10735.It was reported that a perforation occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman® access system (was) along with an unspecified pigtail catheter were inserted into the patient's left atrium.The pigtail was removed since it was not able to gain adequate position in the laa.Then an imager ii angiographic catheter was advanced into the was when a minor perforation was observed.The patient remained stable.Heparin was reversed and vitamin k was ordered.The procedure was aborted.No further complications were reported and the patient status is fine.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that the imager catheter was extended beyond the was.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7013690
• Report Number: 2134265-2017-11353
• Device Sequence Number: 956163
• Product Code: DQO
• UDI-Device Identifier: 08714729355793
• UDI-Public: 08714729355793
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K120893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2017

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 Expiration Date: 12/31/2018
• Device Model Number: M001315051
• Device Catalogue Number: 31-505
• Device Lot Number: 0000120018
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR