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

Model Number	M00566461
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported lot number 2607492 does not match with the reported upn and the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device remains implanted and 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 or Problem Description
It was reported to boston scientific corporation that an endovive safety peg pull method was placed during an esophagogastroduodenoscopy (egd) percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2020.According to the complainant, while the peg tube was being pulled through the incision site, the tube separated.The physician was able to reattach the tube.The procedure was completed with this device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the reported lot number 2607492 does not match with the reported upn and the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6 (device codes): problem code a0501 captures the reportable event of peg tube detached.Block h6 (evaluation conclusion codes): conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device remains implanted and 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 or Problem Description
It was reported to boston scientific corporation that an endovive safety peg pull method was placed during an esophagogastroduodenoscopy (egd) percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2020.According to the complainant, while the peg tube was being pulled through the incision site, the tube separated.The physician was able to reattach the tube.The procedure was completed with this device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety peg pull method was placed during an esophagogastroduodenoscopy (egd) percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2020.According to the complainant, while the peg tube was being pulled through the incision site, the tube separated at the junction between the peg tube and the introducer tube at the skin level.The physician was able to reattach the tube and used t-fastener.The procedure was completed with this device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
The reported lot number 2607492 does not match with the reported upn and the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block g3: medwatch number is (b)(4).Block h6 (device codes): problem code a0501 captures the reportable event of peg tube detached.Block h6 (evaluation conclusion codes): conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device remains implanted and 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.

• Brand Name: ENDOVIVE SAFETY PEG KIT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11158782
• Report Number: 3005099803-2021-00074
• Device Sequence Number: 824107
• Product Code: KNT
• UDI-Device Identifier: 08714729802624
• UDI-Public: 08714729802624
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K031538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2021

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
• Operator of Device: Health Professional
• Device Model Number: M00566461
• Device Catalogue Number: 6646
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 02/04/2021; 03/22/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/05/2021; 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR