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

Model Number M00558780

Device Problem Deflation Problem (1149)

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

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used in the colon during a lower gastrointestinal dilatation procedure performed on (b)(6) 2022.During the procedure, it was noted that the balloon did not drain the liquid solution when they tried to inflate and deflate the device.The same problem occurred with the inflator and the stopcock was removed and deflation was re-performed.Additionally, the device with the scope was removed, the balloon was then crushed manually to remove the liquid solution.The procedure was completed with the original device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: device code a1401 captures the reportable event of balloon failed to deflate.Block h10: investigation results the returned cre pro gi dilatation balloon was analyzed and a visual examination found that the balloon and catheter of the device had no damages.A functional evaluation was performed by attaching the device to an alliance inflation system.The balloon was inflated without problem and hold the pressure, the balloon was deflated and no damages were found.With all the available information, boston scientific concludes the reported event of balloon failure to deflate cannot be confirmed.No damages were found on the returned balloon and it deflated properly during functional testing.Therefore, the most probable root cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used in the colon during a lower gastrointestinal dilatation procedure performed on (b)(6), 2022.During the procedure, it was noted that the balloon did not drain the liquid solution when they tried to inflate and deflate the device.The same problem occurred with the inflator and the stopcock was removed and deflation was re-performed.Additionally, the device with the scope was removed, the balloon was then crushed manually to remove the liquid solution.The procedure was completed with the original device.There were no patient complications reported as a result of this event.

• 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: 15303150
• MDR Text Key: 305498796
• Report Number: 3005099803-2022-04847
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2023
• Device Model Number: M00558780
• Device Catalogue Number: 5878
• Device Lot Number: 0026118103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 09/01/2022
• Supplement Dates FDA Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2020
• 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