MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO GI; DILATOR, ESOPHAGEAL

Model Number M00558780

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2021

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a cre pro wireguided balloon was used during a esophageal dilatation procedure performed on (b)(6) 2021.During withdrawal/closure, the balloon was defective.The procedure was completed with the original device.No patient complications have been reported as a result of the event.

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a cre pro wireguided balloon was used during a esophageal dilatation procedure performed on (b)(6), 2021.During withdrawal/closure, the balloon was defective.The procedure was completed with the original device.No patient complications have been reported as a result of the event.

Manufacturer Narrative

Block h6: device code a04 captures the reportable event of balloon damaged/defective.Block h10: the returned cre wireguided balloon was analyzed, and a visual evaluation noted that the catheter was stretched and detached at approximately 78.9cm from the bifurcation.The balloon was cut and the remaining part didn't return.A microscopic evaluation of the balloon cut noted that a mechanical tool was used to perform the cut.No other problems with the device were noted.The reported event of balloon damaged/defective could not be confirmed because the balloon was cut and the remaining part was not returned for analysis.Additionally it was observed that the catheter was stretched and detached.It is possible that during deflation, the balloon was stuck within the scope and/or other support device during the procedure.Once this condition was present the user may have experienced resistance during the removal of the device which may have caused the user to apply extra force.The extra force may have caused the stretch on the catheter and as consequence detached it.It is possible that the user cut the balloon in order to separate the device from the scope.Based on the analysis performed and all the information gathered from the customer, the root cause of balloon damaged/defective cannot be established since the remaining portion of the balloon was not returned.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: CRE PRO GI
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13172475
• MDR Text Key: 289509205
• Report Number: 3005099803-2021-08094
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558780
• Device Catalogue Number: 5878
• Device Lot Number: 0027801491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2021
• 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