MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) CRE PRO GI; DILATOR, ESOPHAGEAL

Model Number M00558780

Device Problem Inflation Problem (1310)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 02/09/2017

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.It was reported the device was not used past its expiry date.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure 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 gi wireguided balloon was used during an esophageal stenosis dilatation procedure on (b)(6) 2017.According to the complainant, during the first inflation attempt, the balloon failed to expand, so the device was removed from the inflation syringe.After it was reattached to the same syringe, the balloon was re-inflated.However, the balloon expanded largely suddenly and was noted to be too big, which then caused tears in the patient's esophagus.It was reported that the patient had complications due to the lacerations but was "good after treatment", and was confirmed to be stable.

Manufacturer Narrative

Investigation results: a visual examination and product analysis of the returned cre pro gi wireguided balloon found no issues with the device and the balloon inflated well and without delay.This failure is likely due to the inflation device, which was reported to be resterilized, found to have inaccurate readings, and was used with the cre balloon.Inaccurate readings could lead to the reported failure "laceration" since it is not possible to measure how much pressure is being applied to the balloon; a resterilized device would compromise the expected performance during procedure.Therefore, since no issues were found in the cre balloon, the most probable root cause of this complaint is caused by other device.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.

Event Description

It was reported to boston scientific corporation that a cre pro gi wireguided balloon was used during an esophageal stenosis dilatation procedure on (b)(6) 2017.According to the complainant, during the first inflation attempt, the balloon failed to expand, so the device was removed from the inflation syringe.After it was reattached to the same syringe, the balloon was re-inflated.However, the balloon expanded largely suddenly and was noted to be too big, which then caused tears in the patient's esophagus.It was reported that the patient had complications due to the lacerations but was "good after treatment," and was confirmed to be stable.

• Brand Name: CRE PRO GI
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6377203
• MDR Text Key: 69092137
• Report Number: 3005099803-2017-00617
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558780
• Device Catalogue Number: 5878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention