MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SAFETY PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M00566470

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

Report source: medwatch number is mw5097664.(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an endovive safety peg kit push method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure.The procedure date is unknown.According to the complainant, while the patient was cleaning around the peg tube, the internal bolster detached.The patient went to the emergency department and was brought to the gi lab wherein the detached portion was retrieved from the patient's stomach through esophagogastroduodenoscopy (egd).The procedure was completed with a new peg tube.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that an endovive safety peg kit push method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure.The procedure date is unknown.According to the complainant, while the patient was cleaning around the peg tube, the internal bolster detached.The patient went to the emergency department and was brought to the gi lab wherein the detached portion was retrieved from the patient's stomach through esophagogastroduodenoscopy (egd).The procedure was completed with a new peg tube.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block g3: medwatch number is mw5097664.Block h6 (device codes): problem code 2907 captures the reportable event of internal bolster detached.Block h6 (evaluation conclusion codes): the complainant indicated that the device will not be returned for evaluation; therefore a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11 (correction): the manufacturing site address in section g has been corrected (mfr site address 1, mfr site city, mfr site state, mfr site zip/post code).

• Brand Name: ENDOVIVE SAFETY PEG KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11051248
• MDR Text Key: 226334272
• Report Number: 3005099803-2020-06302
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 08714729748397
• UDI-Public: 08714729748397
• Combination Product (y/n): N
• PMA/PMN Number: K031538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2021
• Device Model Number: M00566470
• Device Catalogue Number: 6647
• Device Lot Number: 0026003328
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other