MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC GUIDELINER V3; CATHETER

Model Number	5570
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
When advancing the stent delivery system, the user felt much resistance, so physician tried to withdraw the stent, but it was unable to do it, then the user withdrew the stent and the guideliner together.The case was completed with a new 5.5f guideliner and a new stent.No patient injury was reported.During preliminary inspection of returned device on (b)(6) 2020 it was observed that the rx lumen was missing.The account was inquired on (b)(6) 2020 for further information on the procedure.Response was received on (b)(6) 2020.The vessel was tortuous and severely calcified.It was noted that a whole set of devices were removed together from the patient body and was difficult.The rx lumen is likely to have got stuck within the guide catheter due to concomitant device interaction with other devices such as stent system, guidewire and guide catheter.The separation of the guideliner is likely to have occurred after withdrawal from the body.The account also stated that the separation of the rx lumen did not occur inside the patient body.The separated shaft was not retained and discarded.No other devices were returned for investigation.
Event or Problem Description
When advancing the stent delivery system, the user felt much resistance, so physician tried to withdraw the stent, but it was unable to do it, then the user withdrew the stent and the guideliner together.The case was completed with a new 5.5f guideliner and a new stent.No patient injury was reported.During preliminary inspection of returned device on (b)(6) 2020 it was observed that the rx lumen was missing.The account was inquired on (b)(6) 2020 for further information on the procedure.Response was received on (b)(6) 2020.The vessel was tortuous and severely calcified.It was noted that a whole set of devices were removed together from the patient body and was difficult.The rx lumen is likely to have got stuck within the guide catheter due to concomitant device interaction with other devices such as stent system, guidewire and guide catheter.The account also stated that the separation of the rx lumen did not occur inside the patient body.The separated shaft was not retained and discarded.No other devices were returned for investigation.
Additional Manufacturer Narrative
One-unit of guideliner was returned to vsi/teleflex for evaluation.A returned product evaluation was completed.Kink was noted at 23.5 cm from the proximal hub.The rx lumen was separated from the shaft.The distal separated portion was not returned.Abrasion marks were noted on the half pipe.Damages were noted on the lateral side of the half pipe lumen.Per ifu, it states the following warning and precaution: never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter or guidewire against resistance may result in separation of the catheter or guidewire tip, damage to the catheter, or vessel damage.Exercise care in handling of the catheter during a procedure to reduce the possibility of accidental breakage, bending or kinking.Do not apply torque to the catheter during delivery, as catheter damage may result the account was inquired on procedure details and a response was received.The vessel was tortuous and severely calcified.It was noted that a whole set of devices were removed together from the patient body and was difficult.The rx lumen is likely to have got stuck within the guide catheter due to concomitant device interaction with another device such as stent system, guidewire, and guide catheter.The account also stated that the separation of the rx lumen did not occur inside the patient body.The separated shaft was not retained and discarded.No other devices were returned for investigation.Based on the information and product evaluation, the most likely root cause of the issue is operational context, unintended use error.

• Brand Name: GUIDELINER V3
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11131409
• Report Number: 2134812-2021-00001
• Device Sequence Number: 700942
• Product Code: DQY
• UDI-Device Identifier: 10841156100582
• UDI-Public: (01)10841156100582
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K172090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2022
• Device Model Number: 5570
• Device Catalogue Number: 5570
• Device Lot Number: 672029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR