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

Model Number H7493919320300

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(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 that a shaft break occurred.The target lesion was located in the severely calcified left anterior descending (lad) artery.A 3.00mm x 20mm emerge¿ balloon catheter was advanced to the lad and could not cross the lesion.The catheter was pushed "hard" and broke on a portion outside of the patient, approximately 20cm from the proximal end.There were no patient complications reported and the patient is in good condition.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an emerge balloon catheter.The balloon was tightly folded and there was contrast in the inflation lumen.The balloon, hypotube, inner and outer shafts were microscopically and tactile examined.Inspection revealed numerous kinks in the hypotube, with a separation 16.5 cm from the strain relief.The ends of the separation were oval, as if kinked prior to separation.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 operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that a shaft break occurred.The target lesion was located in the severely calcified left anterior descending (lad) artery.A 3.00 mm x 20 mm emerge¿ balloon catheter was advanced to the lad and could not cross the lesion.The catheter was pushed "hard" and broke on a portion outside of the patient, approximately 20 cm from the proximal end.There were no patient complications reported and the patient is in good condition.

• Brand Name: EMERGE¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• 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: 6185139
• MDR Text Key: 62705048
• Report Number: 2134265-2016-12012
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K113220
• 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: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: H7493919320300
• Device Catalogue Number: 39193-2030
• Device Lot Number: 19405186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2016
• 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