MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY GLADIATOR?; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H74939207060440

Device Problems Device Damaged Prior to Use (2284); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 11/17/2014

Event Type  malfunction  

Event Description

It was reported that balloon tear occurred.A 6.0 x40, 40cm gladiator¿ balloon catheter was selected.During unpacking, it was noticed that the balloon was damaged.It was noted that the tip was bent and appeared to be cracked or tear.The device never entered the patient's body.The procedure was completed with another of the same device.No patient complications were reported.

Event Description

It was reported that balloon tear occurred.A 6.0 x40, 40cm gladiator¿ balloon catheter was selected.During unpacking, it was noticed that the balloon was damaged.It was noted that the tip was bent and appeared to be cracked or tear.The device never entered the patient's body.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

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).

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.A visual and microscopic examination found that the devices tip was bent.This type of damage is consistent with meeting an obstruction.A visual and microscopic examination of the returned device found that the balloon was tightly wrapped, evenly folded and was not subjected to positive pressure.A visual and tactile examination found no kinks or damage along the shaft of the device.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

• Brand Name: GLADIATOR?
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4321584
• MDR Text Key: 5130245
• Report Number: 2134265-2014-07871
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: H74939207060440
• Device Catalogue Number: 3920706044
• Device Lot Number: 17327311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2014
• 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