MAUDE Adverse Event Report: PHILIPS VOLCANO PIONEER PLUS PPLUS120; CATHETER FOR CROSSING TOTAL OCCLUSIONS

Model Number	PPLUS120
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a therapeutic peripheral procedure in a slightly calcified distal sfa and proximal popliteal, the manufacturer's catheter¿s needle did not deploy correctly.The needle was fired at 3 mm but could not be advanced to the true lumen.Therefore, the needle was retracted and the wire was pulled back in to adjust the needle depth to 5 mm, with no success.Then, the catheter was advanced forward 1 cm at a time, deployed the needle and repeated approximately 5 separate times, again with no success.Angiogram showed that the needle appeared to be pointing in a different direction; however, there was no evidence of needle penetrating the incorrect vessel wall.The physician decided to remove the catheter, but it got stuck on the non-manufacturer's wire, thus were removed together as a unit.The needle was fully retracted when removed from the patient.A new manufacturer's catheter and new non-manufacturer''s wire were used to complete the procedure.There was no patient injury reported.This product problem is being submitted because the manufacturer's catheter needle was not pointing in the desired direction.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.The pioneer plus pplus120 was not returned for evaluation, thus no returned product investigation was performed.
Additional Manufacturer Narrative
Blocks d9 & g3: the pioneer plus catheter was returned for evaluation.Block h3: the pioneer plus catheter was visually and microscopically inspected.The tip of the catheter was deformed and a tear was noted at the exit port.During functional testing, the needle could not be deployed due to resistance.However, the needle was intact with no rough/sharp edges or missing material observed.Block h6: the probable cause of the reported "needle misaligned" could not be determined since the needle failed to deploy during evaluation.

• Brand Name: PIONEER PLUS PPLUS120
• Common Device Name: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): PHILIPS VOLCANO; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone &business park; b37; alajuela ; CS
• Manufacturer Contact: ayse yarimoglu ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 13716068
• Report Number: 3008363989-2022-00015
• Device Sequence Number: 17713820
• Product Code: PDU
• UDI-Device Identifier: 00845225002565
• UDI-Public: (01)00845225002565(11)210806(17)230806(10)5161258
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K162418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: 08/06/2023
• Device Model Number: PPLUS120
• Device Catalogue Number: 400-0200.246
• Device Lot Number: 5161258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTT: 0.014" SPARTACORE GUIDEWIRE; LAKE REGION MEDICAL: 0.014" PHOENIX LIGHT SUPPORT; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Sex: Unknown