MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; CATHETER, BILIARY, DIAGNOSTIC

Model Number M00558680

Device Problems Burst Container or Vessel (1074); Use of Device Problem (1670); Difficult to Advance (2920)

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

Event Date 09/30/2022

Event Type  malfunction  

Manufacturer Narrative

B)(4).

Event Description

Note: this report pertains to one of two cre pro wireguided dilatation balloons used in the same patient and procedure.It was reported to boston scientific corporation that two cre pro wireguided dilatation balloons were used in the trachea during an endoscopic tracheal dilation procedure performed on (b)(6) 2022.During the procedure, the distal tip of the balloon ruptured and the device could not pass through the working channel.Additionally, the same issue occurred on the second cre pro wireguided dilatation balloon.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: device code a0402 captures the reportable event of balloon burst.Block h11: correction to field d5: describe event or problem.

Event Description

Note: this report pertains to one of two cre pro wireguided dilatation balloons used in the same patient and procedure.It was reported to boston scientific corporation that two cre pro wireguided dilatation balloons were used in the trachea during an endoscopic tracheal dilation procedure performed on (b)(6) 2022.During the procedure, the distal tip of the balloon ruptured and the device could not pass through the working channel.Additionally, the same issue occurred on the second cre pro wireguided dilatation balloon.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.During the procedure, the distal tip of the balloon ruptured at 3 atm and the device could not pass through the working channel.Additionally, the same issue occurred on the second cre pro wireguided dilatation balloon.The procedure was completed with another cre pro wireguided dilatation balloon.

• Brand Name: CRE PRO
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15671274
• MDR Text Key: 302494138
• Report Number: 3005099803-2022-06261
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729797562
• UDI-Public: 08714729797562
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K112994
• 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: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558680
• Device Catalogue Number: 5868
• Device Lot Number: 0028627292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• 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
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 63 KG