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

Model Number M00558760

Device Problem Material Twisted/Bent (2981)

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

Event Date 12/16/2022

Event Type  malfunction  

Manufacturer Narrative

Device code (b)(4).

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during an esophageal dilatation procedure on (b)(6) 2022.During the procedure, a kink was noted in the distal tip of the balloon.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: device code a040609 captures the reportable event of balloon tip bent.

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during an esophageal dilatation procedure on (b)(6) 2022.During the procedure, a kink was noted in the distal tip of the balloon.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.It was reported that during preparation, outside the patient, a kink was noted in the distal tip of the balloon.

• 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 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: 16131481
• MDR Text Key: 308627857
• Report Number: 3005099803-2022-07950
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558760
• Device Catalogue Number: 5876
• Device Lot Number: 0029839345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2022
• 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