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

Model Number M00558710

Device Problems Leak/Splash (1354); Appropriate Term/Code Not Available (3191)

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

Event Date 03/28/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).(b)(4).According to the complainant, the suspect device has been contaminated and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the colon during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, a leak was noted on the distal end of the balloon.The procedure was cancelled at this time.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the colon during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, a leak was noted on the distal end of the balloon.The procedure was cancelled at this time.There were no patient complications reported as a result of this event.Additional information received on may 4, 2022.It was reported that the procedure was completed with a non-bsc device.

Manufacturer Narrative

Block h2: additional information: block b5 (describe event), block d7a (sud reprocessed and reused), block e1 (initial reporter's last name and initial reporter's phone number), block h6 (impact and device codes) and block h8 (usage of device).Evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device has been contaminated and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

• 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: 14193287
• MDR Text Key: 289976810
• Report Number: 3005099803-2022-02170
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729797593
• UDI-Public: 08714729797593
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

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 Model Number: M00558710
• Device Catalogue Number: 5871
• Device Lot Number: 0028514732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• 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