MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE APEX¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493895915250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	11/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2016-10738; 2134265-2016-10739; 2134265-2016-10744; 2134265-2016-10745; 2134265-2016-10747; 2134265-2016-11383 and 2134265-2016-11384.It was reported that vessel perforation occurred.Two target lesions were identified.The target lesion #1 was located in the mid left anterior descending artery (mlad) and the target lesion #2 was located in the lateral 1st diagonal branch artery.After performing rotablation with a 1.50mm rotalink¿ plus, a 2.5mm x 15mm apex¿ balloon catheter was advanced to the mlad for predilation.The balloon was inflated at 16 atmospheres for 10 seconds.The device was then removed from the mlad and was advanced to the lateral 1st diagonal branch and was inflated at 14 atmospheres for 10 seconds.The device was removed and a 2.5 x 24 synergy ii (des) was advanced to treat the mlad.The stent was deployed at 18 atmospheres for 20 seconds.The stent delivery system was removed and a 3.0 x 12 synergy ii des was then advanced to the lateral 1st diagonal branch.The stent was deployed at 16 atmospheres for 12 seconds and the sds was removed.A 3.25x15mm non-bsc balloon catheter was then advanced to the mlad however the device was eventually removed and was exchanged with a 3.5mm x 15mm apex¿ balloon catheter for post dilation.The balloon was inflated at 13 atmospheres for 16 seconds on the first inflation and at 18 atmospheres for 10 seconds on the second inflation.The device was removed and a 2.5mm x 20mm apex¿ balloon catheter was advanced in the mlad for further dilatations.The balloon was first inflated at 10 atmospheres for 16 seconds, 12 atmospheres for 60 seconds on the second inflation, 16 atmospheres for 90 seconds on the third inflation, 6 atmospheres for 300 seconds on the fourth and fifth inflations and 6 atmospheres for 274 seconds on the sixth inflation.The device was removed and a 3.0mm x 15mm apex¿ balloon catheter was then advanced for further dilatations and the procedure was completed.However, a perforation in the lad was noted.Patient was then re-treated and a stent was deployed in the lad.Electrocardiogram (ecg) was then performed.No further patient complications were reported and the patient's status was stable.

• Brand Name: APEX¿
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6135686
• Report Number: 2134265-2016-10746
• Device Sequence Number: 16183420
• Product Code: LOX
• UDI-Device Identifier: 08714729475613
• UDI-Public: (01)08714729475613(17)20190630(10)19426456
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P860019
• 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
• Report Date (Section B): 11/07/2016

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: 06/30/2019
• Device Model Number: H7493895915250
• Device Catalogue Number: 38959-1525
• Device Lot Number: 19426456
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2016
• Initial Report FDA Received Date: 11/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: .014X190CM WHISPER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR