MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. AV SHEATH TUNNELER; SURGICAL TUNNELER

Catalog Number AVSTS1205

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 10/24/2023

Event Type  malfunction  

Event Description

It was reported that prior to a graft procedure, the item number printed on the sheath was allegedly found to be incorrect.There was no patient contact.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, photo was provided for review.The investigation of the reported event is currently underway.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.

Manufacturer Narrative

H10: manufacturing review: a manufacturing lot review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.One electronic photo was provided and reviewed.The photo shows a portion of an av sheath tunneler.Product code marking avsts1205 can be seen near the end of the device, matching the indications in product drawing.This matches the reported product number in trackwise.No dimensions or size of the device can be determined in the photo.Additionally, product drawing number indicates the outer diameter specification of product code avsts1205 is 0.389 ±.004 inches (9.88 ± 0.10 mm).Per the reported information, the user indicated the received device with marking of avsts1205 was approximately 10mm.Therefore, this device is likely within manufacturing specification.As the reported device size matches the product specifications, the complaint can be unconfirmed.The likely cause of the event is due to a misunderstanding of the size of the device, as the indication of 5mm is for the size of the components used within the tunneler, not for the outer diameter of the av sheath tunneler.Labeling review: product drawing number indicates the outer diameter specification of product code avsts1205 is 0.389 ±.004 inches (9.88 ± 0.10 mm).Additionally, note 7 states "laser mark avsts1205".This marking can be seen in the provided user photos.Per the reported information, the user indicated the received device with marking of avsts1205 was approximately 10mm.Therefore, this device is likely within manufacturing specification, and the issue is due to a misunderstanding of the size of the device.The indication of 5mm is for the size of the components used within the tunneler, not for the outer diameter of the av sheath tunneler.As the reported device size matches the product specifications, the complaint can be unconfirmed.H10: g3, h6 (method).H11: h6 (result, conclusion).H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.

Event Description

It was reported that prior to a graft procedure, the item number printed on the sheath was allegedly found to be incorrect.There was no patient contact.

• Brand Name: AV SHEATH TUNNELER
• Type of Device: SURGICAL TUNNELER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18290173
• MDR Text Key: 330021183
• Report Number: 2020394-2023-01178
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AVSTS1205
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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