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

Model Number	H7493895920250
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that balloon ruptured occurred.The 100% stenosed target lesion was located in a minimally tortuous, severely calcified, right coronary artery.After a guide wire and guide catheter crossed the lesion, a 1.5 x 2.0 balloon catheter was used to successfully dilate the proximal guide catheter.A 2.50mm x 20mm was advanced to treat the lesion and during the third or fourth inflation above rated burst pressure, the balloon ruptured.When the device was pulled out of the patient, a piece of the ruptured balloon was caught in the lesion.The tip of the balloon catheter sheared off and remained in the lesion.The physician tried unsuccessfully to snare the balloon fragment.A surgeon was consulted but the surgeon did not want to take the patient to surgery to remove the fragment so the physician stented the balloon fragment in the ostium of the rca.No patient complications were reported and the patient was doing okay at the end of the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an apex balloon catheter.The distal portion of the balloon and shaft were separated and not returned.The shaft, hypotube, and bonds were microscopically and visually examined.The balloon is completely circumferentially torn 140.8cm from the hub with the distal portion of the balloon not returned.The inner shaft is torn/separated 138cm from the hub with the distal portion of the shaft, markerbands and tip not returned.The fractured/separated end of the shaft is stretched and jagged which indicates the shaft separation was due to tensile forces.There is shaft damage at the exit notch that is consistent with damage seen with the use of a guide wire.There was no evidence of any material or manufacturing deficiencies contributing to the damage.There were numerous hypotube and shaft kinks.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.The product directions for use states do not exceed rated burst pressure.(b)(4).
Event or Problem Description
It was reported that balloon ruptured occurred.The 100% stenosed target lesion was located in a minimally tortuous, severely calcified, right coronary artery.After a guide wire and guide catheter crossed the lesion, a 1.5 x 2.0 balloon catheter was used to successfully dilate the proximal guide catheter.A 2.50mm x 20mm was advanced to treat the lesion and during the third or fourth inflation above rated burst pressure, the balloon ruptured.When the device was pulled out of the patient, a piece of the ruptured balloon was caught in the lesion.The tip of the balloon catheter sheared off and remained in the lesion.The physician tried unsuccessfully to snare the balloon fragment.A surgeon was consulted but the surgeon did not want to take the patient to surgery to remove the fragment so the physician stented the balloon fragment in the ostium of the rca.No patient complications were reported and the patient was doing okay at the end of the procedure.

• 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: 7068395
• Report Number: 2134265-2017-11687
• Device Sequence Number: 10802087
• Product Code: LOX
• UDI-Device Identifier: 08714729475736
• UDI-Public: 08714729475736
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 11/08/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2020
• Device Model Number: H7493895920250
• Device Catalogue Number: 38959-2025
• Device Lot Number: 21157385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 12/18/2017
• 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