MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY XXL¿ ESOPHAGEAL; DILATOR, ESOPHAGEAL

Model Number M001145520

Device Problems Material Perforation (2205); Device Damaged Prior to Use (2284); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that shaft perforation occurred.A 16-4/5.8/75 xxl esophageal balloon catheter was selected to dilate the target lesion.However during tracking of a non-bsc guide wire, the guide wire poked out of the side of the balloon catheter right after the hub.The device was not used and the procedure was completed with another of the same device.Patient's status was good.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.The returned device was attached to an encore inflation unit and inflated to its rated burst pressure with no leaks or drop in pressure noted.The inflation device was verified at its rated burst pressure before and after use with a calibrated pressure gauge.The balloon deflated within the allocated 60 seconds when negative pressure was applied.The deflation time was recorded using the digital timer.A visual and tactile examination identified two kinks at the base of the hub.However, no perforation was evident.This type of damage is consistent with excessive force being applied to the delivery system when being handled.A 0.035inch guide wire was successfully inserted with slight resistance encountered at the base of the hub where the device had been kinked.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 operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

It was reported that shaft perforation occurred.A 16-4/5.8/75 xxl¿ esophageal balloon catheter was selected to dilate the target lesion.However during tracking of a non-bsc guide wire, the guide wire poked out of the side of the balloon catheter right after the hub.The device was not used and the procedure was completed with another of the same device.Patient's status was good.

• Brand Name: XXL¿ ESOPHAGEAL
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5959657
• MDR Text Key: 55024604
• Report Number: 2134265-2016-08244
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2019
• Device Model Number: M001145520
• Device Catalogue Number: 14-552
• Device Lot Number: 0019240212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2016
• 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