MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC PRONTO LP; CATHETER

Model Number 5010

Device Problem Separation Problem (4043)

Patient Problem Death (1802)

Event Date 06/10/2019

Event Type  Death  

Manufacturer Narrative

One pronto lp returned for evaluation.There are no related nonconformances associated to this lot with the top level and subassembly records, therefore supporting the device met material, assembly and performance specifications.Several kinks were found in the shaft.The distal tip was missing; and the polyimide tubing was present but elongated and stretched.The marker band and polyimide tubing were both present, indicating the unit was manufactured correctly.Based on the event details and the damage observed, it is likely the device got caught on a stent and/or calcium; further removal of the device most likely exceeded the tensile force resulting in a separation.

Event Description

(b)(4), mdr 21348-2019-00048; pronto lp: had a problem with a pronto lp.The site used it, removed it and flushed and reinserted it.When they attempted to remove the second time, it was stuck and would not come out.After several attempts to remove, it was removed and found to have the tip mangled and the wire exposed.No one is sure what happened, possibly got stuck in a stent strut.It is reported that the patient was very sick.The catheter has been sent to risk management and report filed.Eventually, they will return the catheter.As of 09jul2019, we have not received the device back for investigation.Patient condition is reported as deceased.Multiple attempts were made to obtain cause of death, and a copy of the medwatch reported as filed by risk malmanagement at site, however, unsuccessful.No cause of death is reported.Excerpt of site case report received 13jun2019.Study date: (b)(6) 2016.3:53:23 a pronto was inserted; 3:54:16 aspirating clot in the circ prox with the pronto lp 6fr; 3:55:01 a pronto lp 6fr was removed; 3.56:40 the new balloon 3.0 x 12 was reinserted and 3:57:52 balloon was inflated to 12 atms for 10 secs; 4:30:32 the patient intubated per anesthesia; 4:35:06 through 4:36:13 multiple balloons were inflated in the circ prox inflated to 12 atms x 10 sec; 4:36:31 balloon removed; 4:38:47 a pronto 6fr was inserted; 4:39:20 aspirating clot in the circ prox with the pronto lp 6fr.4:40:02 a pronto lp 6fr was removed ; 4:45:15 another balloon was inserted ; 4:47:37 through 4:47 :54 two balloons in the lad mid; 4:50:15 code blue paged; 4:51:06 compressions started; 4:53:18 compressions stopped by physician; 4:53:33 compressions restarted; 4:53:48 patient shocked ; 4:54:18 compressions restarted; 4:56:34 in the lad mid balloon was inflated 24 atms x 5 secs.4:57:14 through 5:04:14 compressions restarted several times ; 5:28:50 case ended ; 5:57:49 in the circ prox, there appears to be a 100% stenosis; 5:57:57 in the lad mid, there appears to be 100% stenosis; 5:58:08 in the rca there appears to be a 100% stenosis ; end study-patient disposition ; 6:22:44 vt detected ; 6:22:45 patient shocked ; 6:30:23 patient discharged to critical care bed ; end study-patient disposition ; no complications ; transferred to interventional unit ; interventional outcome: successful.

• Brand Name: PRONTO LP
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 8782133
• MDR Text Key: 150804896
• Report Number: 2134812-2019-00048
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2021
• Device Model Number: 5010
• Device Lot Number: 644131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2019
• 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
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 66