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

Model Number M00568390

Device Problems Difficult to Advance (2920); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown at this time.(b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that an endovive standard peg kit pull method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, there is total displacement of the peg tube reportedly because there was a dysfunctional probe due to ball damaged.There were no reported patient complications as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown at this time.Block e1 (initial reporter address 1): (b)(6).Block h6 (device codes): problem code 2920 captures the reportable event of feeding tube difficult to advance (difficult to place) problem code 2978 captures the reportable event of internal bolster damaged.Block h6 (evaluation conclusion codes): the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure 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 standard peg kit pull method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, there is total displacement of the peg tube reportedly because there was a dysfunctional probe due to ball damaged.Additionally, the peg tube moves from the target site and was then removed.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that an endovive standard peg kit pull method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, there is total displacement of the peg tube reportedly because there was a dysfunctional probe due to ball damaged.Additionally, the peg tube moves from the target site and was then removed.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Additional information received on 03feb2020: d4 (lot number, expiration date) h4 (device manufacture date) additional information received on 08jan2020: a1 (patient identifier), a1 (date of birth), b5 (date of event), b5 (describe event or problem), e1 (initial reporter title, first name and last name), e2 (health professional), e3 (occupation), h6 (evaluation conclusion codes), h6 (device codes), h6 (patient codes).Block e1 (initial reporter address 1): (b)(6).Block h6 (device codes): problem code 2920 captures the reportable event of feeding tube difficult to advance (difficult to place) problem code 2978 captures the reportable event of internal bolster damaged.Block h6 (evaluation conclusion codes): the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure 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 STANDARD 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: 8935208
• MDR Text Key: 155669057
• Report Number: 3005099803-2019-04284
• Device Sequence Number: 1
• Product Code: KNT
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2020

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: 02/26/2022
• Device Model Number: M00568390
• Device Catalogue Number: 6839S
• Device Lot Number: 0023412755
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 01/08/2020; 02/03/2020
• Supplement Dates FDA Received: 01/16/2020; 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR